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Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Nov 1, 2026 → Feb 1, 2027
See other at-risk trials from Northside Hospital, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Nov 1, 2026 to Feb 1, 2027
    • Study completion pushed from Dec 1, 2026 to Jun 1, 2027
    • Eligibility criteria expanded, about 11 words
    • Publications: details revised at 9 of 9 entries
  2. Minor Re-verified, no change to tracked fieldsv11
  3. Notable Primary completion date: Nov 1, 2025 to Nov 1, 2026
    • Study completion date: Dec 1, 2025 to Dec 1, 2026
    v10
  4. Minor 2 versions Re-verified since Apr 11, 2025, no change to tracked fieldsv8-v9
  5. Notable Primary completion date: Nov 1, 2024 to Nov 1, 2025
    • Study completion date: Aug 1, 2025 to Dec 1, 2025
    v7
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  1. Minor 2 versions Re-verified since Apr 12, 2024, no change to tracked fieldsv5-v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2023 to Jun 30, 2023
    • Site details revised
    v4
  3. Notable Start date: Nov 1, 2022 to May 1, 2023v3
  4. Notable Primary endpoint revised
    • Secondary endpoints revised (2)
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.
Trial Details
NCT Number NCT05519579
Lead Sponsor Northside Hospital, Inc.
Conditions
(from sponsor)
Acute Lymphoblastic Leukemia
Related terms Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov